Randomized, Parallel Controlled, Clinical-trial on 532nm Laser Partially Subthreshold Panretinal Photocoagulation With PASCAL Endpoint Management Function for Severe Non-proliferative Diabetic Retinopathy(NPDR)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- the probability of vitreous haemorrhage
研究概览
简要总结
This randomized, parallel controlled, clinical-trial aims to evaluate the therapeutic efficacy of 532nm laser partially subthreshold panretinal photocoagulation with PASCAL endpoint management function for severe non-proliferative diabetic retinopathy.
详细描述
This randomized, parallel controlled, clinical-trial aims to evaluate the therapeutic efficacy of 532nm laser partially subthreshold panretinal photocoagulation with PASCAL endpoint management function for severe non-proliferative diabetic retinopathy : (1)To evaluate therapeutic effect of 532nm laser partially subthreshold panretinal photocoagulation with PASCAL endpoint management function for severe non-proliferative diabetic retinopathy; (2)To compare side effect of 532nm laser partially subthreshold panretinal photocoagulation with PASCAL endpoint management function on retina with traditional visible endpoint panretinal photocoagulation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of severe non-proliferative diabetic retinopathy
- •Age:45-80 years
- •Best corrected visual acuity(BCVA) ≥20/100,Myopia≤-6 degree(-6D)
- •No photocoagulation (PRP) before this clinical trial and no major ocular surgery (including cataract extraction, or any other intraocular surgery) within 3 months
- •Ability and willingness to provide informed consent
排除标准
- •Participate in other clinical trials within 3 months
- •Severe refractive media turbidity; Unable to accept laser treatment such as nystagmus, etc
- •Medically or mentally unstable(including cardiovascular disorders, cerebrovascular diseases,liver and kidney disease,hematological disorder and psychosis
- •Conditions that in the opinion of the investigator would interfere trial results or increase risk
- •Conditions that in the opinion of the investigator would preclude participation in the study
研究组 & 干预措施
T-PRP
532nm-short pulse panretinal photocoagulation with PASCAL function
干预措施: T-PRP (Radiation)
S-PRP
532nm-partially subthreshold short pulse panretinal photocoagulation with PASCAL endpoint management function
干预措施: S-PRP (Radiation)
结局指标
主要结局
the probability of vitreous haemorrhage
时间窗: 1 year
change of best corrected visual acuity
时间窗: 1 year
best corrected visual acuity
次要结局
- amount of bard exudate(1 year)
- amount of retinal hemorrhage(1 year)
- amount and area of IRMA(1 year)
- foveal volume of macula(1 year)
- amount of neovascularization(1 year)
- Central Retinal Thickness(1 year)
- amount of microaneurysms(1 year)
- change of ischemia area(1 year)
研究者
Jin Chen-jin
Dr
Sun Yat-sen University